inforMED
MalfunctionFEN

T-DOC URODYNAMIC CATHETER

Received Mar 31, 2017 · Event occurred Mar 10, 2017

Report 6449177 · MDR key 6449177

Device

Generic name

Device, Cystometric, Hydraulic

Catalog number

TDOC-7FD

Lot number

161496

Product problems

  • Fluid/Blood Leak
  • Hole In Material

Patient

Not reported

  • No Information
  • No Information

Narrative

Additional Manufacturer Narrative

UNIQUE DEVICE IDENTIFIER (UDI): FOR TYPE OF DEVICE: DEVICE, CYSTOMETRIC, HYDRAULIC.

Description of Event or Problem

AT THE "Y" WHERE THE TWO CATHETERS MEET, IT WAS LEAKING FROM THERE...WE WERE UNABLE TO USE, THERE MUST HAVE BEEN A SMALL HOLE IN THE TUBING AT THAT POINT.

Description of Event or Problem

AT THE "Y" WHERE THE TWO CATHETERS MEET, IT WAS LEAKING FROM THERE...WE WERE UNABLE TO USE, THERE MUST HAVE BEEN A SMALL HOLE IN THE TUBING AT THAT POINT.